Phase I Randomized Study of CPX for the Treatment of Adult Patients With Mild Cystic Fibrosis
OBJECTIVES: I. Evaluate the safety of ascending doses of CPX administered to adult patients with mild cystic fibrosis.
II. Evaluate the pharmacokinetics of ascending doses of CPX in this patient population.
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Study Start Date:||September 1997|
|Estimated Study Completion Date:||October 1999|
PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, dose escalation study.
There are 7 experimental cohorts, each treated with a different oral dose of CPX or placebo. Within each cohort, 4 patients receive a single dose of CPX and 1 patient receives placebo. Each patient is monitored 24 hours postdose. Escalation to the next dose level for each subsequent cohort begins only after the safety data obtained from the previous cohort is reviewed and found not to limit dose escalation.
All patients return for a follow up evaluation 1 week after dosing.
|Study Chair:||Eduardo Martins||SciClone Pharmaceuticals|